Condition category
Circulatory System
Date applied
06/04/2005
Date assigned
07/06/2005
Last edited
26/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S Mendis

ORCID ID

Contact details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland
mendiss@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC050

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hypertension

Intervention

20 primary health care facilities.
10 facilities to apply the study protocol based on Scenario One of the WHO CVD-Risk Management Package (intervention sites).
Other 10 to continue with conventional treatment or usual care (control sites).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

07/05/2004

Overall trial end date

07/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 30 - 70 years
2. Currently not under treatment for hypertension
3. Systolic blood pressure between 140 and 179 mmHg measured twice with a 5 to 10 minute interval
4. Informed consent given

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Pregnancy
2. Trauma (injury) as presenting complaint
3. Renal diseases: nephropathy, renal artery stenosis
4. Endocrinological (hormonal) disorders: phaechromocytoma, Cushing syndrome, Conn syndrome, acromegaly
5. Coarctation of the aorta
6. Use of steroids and/or non-steroidal anti-inflammatories (NSAIs)
7. All acute conditions presenting with bleeding, pain, diarrhoea, vomiting, breathing disorders and circulatory disorders
8. Inability to comply with the follow-up requirements
9. Inability to provide informed consent

Recruitment start date

07/05/2004

Recruitment end date

07/05/2005

Locations

Countries of recruitment

Sri Lanka

Trial participating centre

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor information

Organisation

The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland)

Sponsor details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

The Department of Cardiovascular Diseases (CVD)/World Health Organization (WHO) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes